medical device pilot manufacturing

Your partner from pilot to full-scale production—or anywhere in between

NextPhase will collaborate with your team to reliably and cost-effectively manufacture your product on time. With solid experience in all phases of medical device development and commercialization, we’re comfortable entering the process at any stage. We can help with your project at its inception or midway through development, and can also handle manufacturing transfers.

Pilot manufacturing process

Pilot manufacturing is a critical step in the path to full device commercialization. NextPhase will develop an early Pilot process that can measure and capture the device’s build time and quality performance. This Pilot line will be iteratively improved implementing fast failure process changes to confirm that the design can be manufactured to meet the client’s business needs for price and performance.

The lessons learned from the Pilot build will inform the decisions for increasing the scale of the process. To scale manufacturing NextPhase will design and/or implement tooling, automation systems, manufacturing space, flow path efficiencies and materials management techniques to maximize efficiencies.

Full scale manufacturing
  • FDA Registered and ISO 13485 certified
  • Manufacturing areas including clean room and cellular assembly areas
  • Low-to medium volume / high mix assembly
  • Incoming inspection and warehousing controls
  • Component and system level testing
  • Enterprise resource planning (ERP) tracking
  • Supply chain management including approved supplier program
Stringent standards

Whether we are supporting pilot production for clinical trials or full-volume manufacturing, NextPhase employs the same stringent LEAN manufacturing systems and standards required for medical devices. All programs coming into NextPhase go through an extensive design for manufacturability (DFM) process (if the customer approves) and design transfer process to review every portion of the documentation package. As we enter details into our MRP/ERP system, we look for economies of scale and manufacturing efficiencies then forecast end-of-life scenarios for components.

Added value

NextPhase will also package and distribute your product, either to your distribution center or directly to your customers—another added value for NextPhase customers.

In-house capabilities include:

  • Design for manufacturability (DFM)
  • Design transfer
  • Fulfillment
  • Manufacturing
  • Product design and development
  • Verification and validation

Have a question about our capabilities?